PDUFA date set for Aug. 30, 2017
SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals
(NASDAQ:AGIO) today announced that the U.S. Food and Drug Administration
(FDA) has accepted Celgene's New Drug Application (NDA) for enasidenib
(AG-221/CC-90007) for the treatment of patients with relapsed or
refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase
2 (IDH2) mutation. The NDA was granted Priority Review and has been
given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30,
2017. Celgene completed the NDA submission in late December 2016.
"We accelerated this application - submitting the NDA just three years
after the first patient was treated in the enasidenib pivotal
investigational trial - because we believe that there is a significant
unmet need for people with relapsed or refractory AML," said Michael
Pehl, president, Hematology/Oncology for Celgene. "The acceptance of the
enasidenib NDA is a significant milestone in what we hope will be a new
era of molecularly targeted therapies for patients with this devastating
Enasidenib is a first-in-class, oral, targeted inhibitor of mutant IDH2.
The NDA submission is based on results from AG221-C-001, a single-arm
phase I/II study of enasidenib in patients with advanced hematologic
malignancies with an IDH2 mutation. Early data from the relapsed or
refractory AML patients in this study were presented at the 2015
American Society of Hematology (ASH) Annual Meeting.
"Having received NDA acceptance and priority review for enasidenib, we
look forward to working with our partner Celgene and the FDA to advance
a first-in-class therapy for relapsed or refractory AML with an IDH2
mutation," said David Schenkein, M.D., chief executive officer at Agios.
"We hope that the continued adoption of molecular profiling and
availability of new targeted therapies such as enasidenib will have a
significant impact on patients living with AML."
Additionally, Abbott has submitted a Premarket Approval (PMA)
application for the FDA approval of an IDH2 assay on the Abbott m2000
RealTime System, a polymerase chain reaction (PCR) molecular
diagnostics instrument. IDH2 mutations occur in about 8 to 19 percent of
AML patients. Recent publications have highlighted the advances in the
understanding of the genetics underlying AML and the need for routine
mutational analysis at diagnosis and relapse.
Celgene is also evaluating enasidenib compared with conventional therapy
in older patients with an IDH2 mutation and relapsed or refractory AML
in the ongoing phase III IDHENTIFY trial (NCT02577406).
Enasidenib is an investigational drug that has not been approved for any
use in any country.
About Acute Myelogenous Leukemia (AML)
AML, a cancer of blood and bone marrow characterized by rapid disease
progression, is the most common acute leukemia affecting adults.
Undifferentiated blast cells proliferate in the bone marrow rather than
mature into normal blood cells. AML incidence significantly increases
with age, and according to the American Cancer Society, the median age
of onset is 66. Less than 10 percent of U.S. AML patients are eligible
for bone marrow transplant and the vast majority of patients do not
respond to chemotherapy and progress to relapsed/refractory AML. The
five-year survival rate for AML is approximately 20 to 25 percent. IDH2
mutations are present in about 8 to 19 percent of AML cases.
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through
next-generation solutions in protein homeostasis, immuno-oncology,
epigenetics, immunology and neuro-inflammation. For more information,
please visit www.celgene.com.
Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
Agios is focused on discovering and developing novel investigational
medicines to treat cancer and rare genetic diseases through scientific
leadership in the field of cellular metabolism. In addition to an active
research and discovery pipeline across both therapeutic areas, Agios has
multiple first-in-class investigational medicines in clinical and/or
preclinical development. All Agios programs focus on genetically
identified patient populations, leveraging our knowledge of metabolism,
biology and genomics. For more information, please visit the company's
website at www.agios.com.
About Agios/Celgene Collaboration
Enasidenib is part of Celgene's global strategic collaboration with
Agios focused on cancer metabolism. Under the terms of the 2010
collaboration agreement, Celgene has worldwide development and
commercialization rights for enasidenib. Agios continues to conduct
clinical development activities within the enasidenib development
program and is eligible to receive reimbursement for those development
activities and up to $120 million in payments assuming achievement of
certain milestones and royalties on net sales. Celgene and Agios intend
to co-commercialize enasidenib in the U.S. Celgene will reimburse Agios
for costs incurred for its co-commercialization efforts.
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
similar expressions. Forward-looking statements are based on
management's current plans, estimates, assumptions and projections, and
speak only as of the date they are made. Neither Celgene nor Agios
undertake any obligation to update any forward-looking statement in
light of new information or future events, except as otherwise required
by law. Forward-looking statements involve inherent risks and
uncertainties, most of which are difficult to predict and are generally
beyond each company's control. Actual results or outcomes may differ
materially from those implied by the forward-looking statements as a
result of the impact of a number of factors, many of which are discussed
in more detail in the Annual Report on Form 10-K and other reports of
each company filed with the Securities and Exchange Commission.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170301005785/en/
Kendra Adams, 617-844-6407
Director, Investor & Public Relations
Senior Manager, Investor & Public Relations
Associate Director, Corporate Communications
Source: Celgene Corporation
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